olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Generic: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2238
Product ID 63629-2238_8def81ed-0ec3-4756-a999-962107b62ef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206137
Listing Expiration 2026-12-31
Marketing Start 2016-10-26

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292238
Hyphenated Format 63629-2238

Supplemental Identifiers

RxCUI
999967
UNII
864V2Q084H 0J48LPH2TH 6M97XTV3HD
NUI
N0000175359 N0000175419 M0471776

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide (source: ndc)
Application Number ANDA206137 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 12.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-2238-1)
source: ndc

Packages (1)

63629-2238-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-2238-1)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8def81ed-0ec3-4756-a999-962107b62ef5", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["864V2Q084H", "0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["999967"], "spl_set_id": ["44dc874b-4377-46eb-ae32-8d84c9c4d4ae"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-2238-1)", "package_ndc": "63629-2238-1", "marketing_start_date": "20161026"}], "brand_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "product_id": "63629-2238_8def81ed-0ec3-4756-a999-962107b62ef5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "63629-2238", "generic_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "ANDA206137", "marketing_category": "ANDA", "marketing_start_date": "20161026", "listing_expiration_date": "20261231"}